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Immunotherapy combo aims to beat back recurrent nasopharyngeal cancer

NCT ID NCT05340491

Disease control Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding an immunotherapy drug called toripalimab to standard chemoradiotherapy helps people with recurrent nasopharyngeal carcinoma live longer. About 212 participants whose cancer has returned after prior treatment and who cannot have surgery will be randomly assigned to receive either chemoradiotherapy alone or chemoradiotherapy plus toripalimab. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Toripalimab (an immunotherapy drug) combined with chemotherapy (gemcitabine and cisplatin) and radiation therapy
What this could lead to
If successful, this combination could improve survival and control of recurrent nasopharyngeal cancer, offering a new treatment option for patients who cannot have surgery.
What could go wrong
This is a phase 3 trial, but results are not yet available. Immunotherapy can cause immune-related side effects, and the added benefit over standard chemoradiotherapy is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 212 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosed as local with or without regional recurrence after ≥1 year of radical treatment; * Not suitable for surgery; * Histologic diagnosis of NPC (WHO II/III); * TNM stage rII-IVa (AJCC/UICC 8th); * ECOG 0-1 point; * No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy; * No contraindications to immunotherapy or chemoradiotherapy; * Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L; * Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN; * Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula); * Take effective contraceptions during and two months after treatment; * Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: * Treated with anti-tumor Chinese medicine treatment; * Have recurrence with local necrosis; * Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa; * Unexplained fever \> 38.5, except for tumor fever; * Treated with ≥ 5 days antibiotics one month before enrollment; * Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive; Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway; * Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; * Have known allergy to large molecule protein products or any compound of study therapy; * Pregnant or breastfeeding; * Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma; * Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial; * Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.

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Conditions

The condition(s) this trial relates to.

nasopharyngeal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nasopharyngeal carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    NOT_YET_RECRUITING

    Shanghai, China

  • Fujian Province Cancer Hospital

    NOT_YET_RECRUITING

    Fuzhou, China

  • Guizhou Cancer Hospital

    NOT_YET_RECRUITING

    Guiyang, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, China

  • Sichuan Cancer Hospital

    NOT_YET_RECRUITING

    Chengdu, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, China

  • The First Affiliated Hospital of Xiamen University

    NOT_YET_RECRUITING

    Xiamen, China

  • Xijing Hospital

    RECRUITING

    Xi'an, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, China

  • Zhongnan Hospital of Wuhan University

    RECRUITING

    Wuhan, China

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